To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment:

0

Detailed Description:

HIV-infected children are randomized to receive adjunctive therapy with intravenous methylprednisolone or placebo. Treatment is administered for 10 days. Primary antipneumocystis therapy with TMP/SMX or systemic pentamidine is selected by the individual investigator and given for 21 days. Patients are stratified at the time of randomization by the presence or absence of respiratory failure.

Eligibility

Ages Eligible for Study:

up to 2 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Recombinant erythropoietin and any FDA-approved cytokine for management of anemia.

Antiretroviral agents.

Patients must have:

Documented HIV infection.

PCP.

No more than 36 hours of prior primary therapy for confirmed or presumed PCP.

Prior Medication:

Allowed:

Up to 35 hours of primary therapy for confirmed or presumed PCP.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Demonstrated intolerance to steroids.

Requirement for steroids at greater than physiological doses for other medical conditions.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000741